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世基基因檢測套組 獲韓國上市許可 KFDA approval for HLA-B*5801 kit

HLA-B*5801 testing obtained South Korea MFDS approval of class III medical devices. Phargmigene is going to provide kits for major medical centers and clinical laboratories in Korea from November.

Allopurinol, one of the most cheap and effecitve drug to treat gout and reduce uric acid levels, is also the top ten culpritdrugs that induce Stevens-Johnson Syndomes (SJS)/Toxic Epidermal Necrolysis (TEN). HLA-B*5801 testing is for preventing allopurinol-induced cutaneous adverse drug reactions.

Obtaining the certificate of KGMP and class III IVD approval in Korea is an inspiring boost for Pharmigene to expand market abroad.